GVP Update 2017

Eudralex Volume 9: The European Medicines Agency (EMA ) recently published the final versions of GVP (Guidelines on Good Pharmacovigilance Practices)

  • Introductory cover note (last updated with revision 2 of module VI on ICSRs finalized post-public consultation, its new addendum on duplicate management and the considerations chapter IV on the paediatric population for public consultation), last updated on 12 October 2017
  • Module II – Pharmacovigilance system master file (Rev 2),
  • Module V – Risk management systems (Rev 2),
  • Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2),
  • Module VI Addendum I – Duplicate management of suspected adverse reaction reports (New), and
  • Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2). 

Furthermore a draft of Product- or Population-Specific Considerations IV: Paediatric population had been published for comments until October 13, 2017. According to EMA, drafts of Product- or Population-Specific Considerations III: Pregnancy and breast-feeding and Product- or Population-Specific Considerations V: Geriatric population are expected to be released for public consultation in the first quarter of 2018.

The GVP-Module V (effective since March 31, 2017) covers the topic risk management. Additionally the template for preparation of a Risk Management Plan (RMP) for initial marketing authorization application has been revised (Rev 2). Its use for all RMP submissions becomes mandatory as of 31 March 2018. EMA states that "RMPs submitted for initial marketing authorization applications and D121 responses applying GVP Module V Rev 1 will be accepted for a further six months (until September 30, 2017), and all other RMP submissions (including D91 responses for an initial application under accelerated assessment) will be accepted for one further year until 31 March 2018".

As reported in EMA publishes GVP Module V for public comment, the following changes have been incorporated in the document:

  • further clarification of what RMPs should focus on in relation to an important identified or important potential risk and missing information;
  • removal of duplication within GVP Module V;
  • removal of duplication of information in other guidance documents;
  • further guidance on the expected changes in the RMP during the life cycle of the product;
  • updated requirements for different types of initial marketing authorization applications, with the aim to create risk-proportionate, fit for purpose RMPs.

As reported in the previous GVP Update the following modifications have been made to GVP Module VI (effective as of November 22, 2017):

  • Updated guidance on ICSRs (Individual Case Safety Reports) submission, follow-up, duplicate detection and data quality management, taking into account the implementation of the new EudraVigilance system, and of the simplified submission of ICSRs in the EU in line with the provisions provided in Article 24 of Regulation (EC) No 726/2004 and Article 107 and 107a of Directive 2001/83/EC;
  • Updated guidance on the validation of ICSRs based on patients and reporters identifiability;
  • Updated guidance on the management of ICSRs described in the medical literature;
  • Updated guidance on the collection of information on patient’s age;
  • Updated guidance on the management of suspected adverse reactions reported through medical enquiry and product information services;
  • New guidance on the electronic submission modalities of ICSRs under the new ICH-E2B(R3) format;
  • New guidance on the management of individual reports of off-label use, based on the Reflection Paper on Collecting and Reporting Information on Off-label Use in Pharmacovigilance (EMA/293194/2016), published for public consultation in 2016;
  • New guidance on the management of reports from post-authorization efficacy studies;
  • Transfer of the guidance on emerging safety issue to GVP Module IX (Signal management, revised version valid as of today, 22 November 2017);
  • Editorial amendments to align the format with other GVP Modules.

For more Information please visit the EudraLex - Volume 9 Pharmacovigilance Guidelines website.

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